FearLess in NeuroOncology

Overseen By Mary Bridgman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cognitive impairment, Informed consent issues, Internet issues

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching goal of this project is to assess the feasibility, acceptability, and appropriateness of recruitment methods, target population, and a waitlist design to finalize the protocol of FearLess in primary malignant brain tumor patients and caregivers

Who Is on the Research Team?

Ashlee R Loughan, Ph.D

Principal Investigator

Virginia Commonwealth University

Sarah E Braun, Ph.D.

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

Inclusion Criteria

I often feel very worried about my cancer coming back.

I have been diagnosed with a grade II-IV primary brain tumor.

It has been more than 2 weeks since my brain surgery or biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

Participants receive the FearLess psychological intervention immediately following enrollment, consisting of an intake and 8 weekly virtual therapy sessions over 12 weeks

12 weeks

9 virtual sessions

Delayed Treatment Control

Participants in the control arm undergo a 12-week no-treatment period before starting the FearLess intervention, which consists of an intake and 8 weekly virtual therapy sessions over 12 weeks

24 weeks

9 virtual sessions after 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

How Is the Trial Designed?

Group I: Fearless Immediate Treatment Arm Experimental Treatment 1 Intervention

FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. FearLess will be delivered immediately following enrollment in this arm.

Group II: FearLess Delayed Control Arm Experimental Treatment 1 Intervention

FearLess is a newly developed, empirically-rooted, manualized psychological intervention consisting of an intake + 8 sessions delivered over a 12-week time period. It consists of weekly individual 60- to 90-minute virtual therapy sessions. In this arm, the FearLess intervention will begin following a 12-week no-treatment period.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Brain Tumor Society

Collaborator